Coaptation ultrasound devices and methods of use

ABSTRACT

Disclosed is a system and method for the placement of elongate medical members within a patient’s body using coaptive ultrasound that combines magnetic guidance with ultrasound visualization of the medical member in the patient’s body. A coaptive ultrasound probe adaptor magnetically attracts an elongate medical member within the patient with sufficient force so as to allow the operator to manually guide the member to its intended location. The adaptor mates with an ultrasound probe to provide the medical operator ultrasound feedback of the position of the member, thus allowing internal placement without the need for more specialized medical equipment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.16/544,518, filed Aug. 19, 2019, which is a continuation of U.S. Pat.Application Serial No. 14/785,366, filed Oct. 19, 2015, now U.S. Pat.No. 10,383,595, issued Aug. 20, 2019, which claims priority under 35U.S.C. §371 to, and is a U.S. national phase entry of, InternationalApplication No. PCT/US2014/034950, filed Apr. 22, 2014, which is basedupon and claims priority from U.S. Provisional Pat. Application SerialNo. 61/814,516 entitled “Coaptation Ultrasound Devices and Methods ofUse,” filed with the U.S. Pat. and Trademark Office on Apr. 22, 2013,the entire contents of each of which are herein incorporated byreference.

FIELD OF THE INVENTION

The present invention relates generally to placement of medical deviceswithin a body in the medical field, and more particularly to methods anddevices for ultrasound-guided placement of medical devices, such ascatheters, conduits, carriers, electrodes, and the like into a patient’sbody.

BACKGROUND OF THE PRIOR ART

A wide variety of medical procedures require placement of medicaldevices at various locations within a patient’s body. For instance,certain procedures may require the placement of electrodes within apatient’s spine, or attachment of electrodes to heart tissue, or thelike. In other procedures, medical staff may wish to place temperatureprobes or heating wires at various locations within patient’s body.Further, for cancer treatment, medical staff may wish to placeradioactive seeds or deliver therapeutic medications deep within apatient’s body, including directly into internal organs. In still otherprocedures, medical staff may wish to place catheters or other fluid ormaterial-carrying conduits within the patient’s body for delivery ofmedications or other materials, for carrying forceps, biopsy instrumentsor the like into the patient’s body, for providing suctioning to variousparts of a patient’s body, and many other procedures involving theplacement of medical devices within the patient’s body. Procedures forplacing such medical devices vary widely from application toapplication, but all carry the common aspect of presenting challenge tothe medical staff in manipulating such medical devices within thepatient’s body to route them to their intended location and positionthem for their intended use at that location.

More particularly, often times medical procedures require manipulationof a catheter or other conduit through portions of the patient’s bodythat are not easily accessible, and thus make maneuvering of the conduitto its intended location quite challenging. For instance, it may bemedically necessary to place conduits within internal body cavities toprovide for the drainage of unwanted fluid, to provide for the infusionof medications into internal organs or elsewhere in the body, to providefor direct nutritional supplementation to patients unable to orallyconsume adequate nutrition, and the like. The procedures for guidingsuch conduits to their intended locations in a patient’s body can bedifficult to perform and can risk serious injury to the patient if notperformed properly.

One such procedure that presents significant challenges is the placementof gastrostomy tubes for patients requiring direct nutritionalsupplementation into the stomach. Enteral feeding has been recommendedwhen a patient has a functioning gut but is unable to eat for seven tofourteen days. When enteral feeding is anticipated to be required forlonger than 30 days, a gastrostomy tube is preferred over a nasoenterictube. The placement of gastronomy tubes has become a frequently requiredprocedure, with more than 215,000 being placed annually in the UnitedStates. The vast majority of such procedures are performed byconsultants, such as gastroenterologists and interventionalradiologists, as opposed to an emergency room doctor, an intensivist, orpatient’s primary physician. This is because those specializedconsultant physicians have access to and have been trained on theexpensive equipment that one must use to safely enter (i.e., cannulate)the stomach (i.e., gastrostomy). This expensive equipment includesendoscopes, fluoroscopes, and computed tomography (CT) scanners, all ofwhich require specialized training and skill to operate properly.

The most common method for initial gastrostomy tube insertion isPercutaneous Endoscopic Gastrostomy (“PEG”), involving placing of a PEGtube into the patient’s stomach. When performing a typical PEG process,a patient is placed in the supine position. A nasal or oral gastric tubeis then introduced into the patient’s stomach. Gastric fluid is removedusing suction, such as through fenestrations at the distal end of thenasal or oral gastric tube. The stomach is then insufflated by way ofthe gastric tube or an endoscope. In one method, the endoscope has alight at the distal end. When illuminated, the practitioner is supposedto identify a suitable puncture site that is free from interposed organsand large vessels by noting where the light from the endoscope shinesthrough the abdominal skin of the patient. An incision is then made atthe identified target site, and a sheathed needle is then entered intothe insufflated stomach. A guide wire is then introduced through theabdominal sheath and into the stomach. A snare or forceps located at thedistal end of the endoscope is manipulated to capture the end of theguide wire. The endoscope is then extracted, pulling the guide wirealong and ultimately causing the guide wire to exit through the mouth ornose. Applicant is aware of two preferred methods to complete thegastrostomy after the guide wire has been routed from the outside of thepatient’s abdomen, into their stomach, up their esophagus and outthrough their mouth or nose: the Ponsky-Gauderer (pull-(on) string)method (the “PG method”), and the Sacks-Vine (push-over-wire) method(the “SV method”).

If the PG method is selected, the gastrostomy tube is tied to the end ofthe guide wire that has exited through the patient’s nose or mouth. Theabdominal end of the guide wire is then pulled until the gastrostomytube extends out from the hole in the abdomen, with the proximal end ofthe gastrostomy tube (having an enlarged end, or bumper, therein toprevent it from passing through the stomach wall and out of thepatient’s abdomen) remaining within and providing access to the interiorof the patient’s stomach. If the SV method is selected, the gastrostomytube is placed over the guide wire and is pushed toward the stomach fromthe patient’s mouth until it extends out from the abdominal hole. Again,the gastrostomy tube has a bumper to prevent the tube from passingentirely through the abdominal hole and causing the proximal end toremain in the stomach.

Alternatively, percutaneous gastrostomy placement can be performed usinggastropexy methods. Gastropexy wires are inserted into the stomach viathe angiocatheter and used to tether the stomach. Standard gastropexytechniques are then used to place the gastrostomy tube over a guide wireinserted only within the stomach.

Even with skilled consultant physicians handling these procedures,complications can occur including tube misplacement, inadvertent injuryto surrounding tissues during placement, infections, tube clogging, andtube dislodgement during use. When such complications occur outside ofthe hospital, patients will often come to a hospital emergency room forhelp. However, as the PEG procedures require specialized skill inhandling, emergency medicine physicians are often unable to perform thenecessary procedures, and must instead call upon such specialistconsultants, which adds to the overall expense and delay in treating thepatient’s issue, or risk of further complication or injury if someonelacking sufficient specialized skill attempts to address the issue.

Accordingly, there is a need in the art for a device and method thatwill allow for placement of a medical device into a patient’s body, suchas the performance of percutaneous gastrostomies, at the bedside andthat will no longer require the expertise and equipment of specialistmedical personnel, such as a gastroenterologist or other specialist. Itwould be advantageous to provide a method and device that would reducethe difficulties associated with installing medical devices inside of apatient’s body, including medical instrument carriers, medicationcarriers, electrodes, probes, catheters and other conduits, and thatwould thereby reduce the risks of injury associated with previouslyknown methods and devices.

DESCRIPTION OF THE INVENTION

Disclosed herein is a system and method for placement of a catheter,conduit, or other elongate member within a patient’s body that utilizescoaptive ultrasound that combines magnetic guidance with ultrasoundvisualization of the elongate member in the patient’s body. Such systemand method are suitable for use in therapeutic interventional and /ordiagnostic procedures, and may be useful for placement and guiding ofmedical devices, including catheters or other conduits, in varied tissueplanes and cavities in a patient’s body, including by way ofnon-limiting example the thorax, abdomen, blood vessels, andpericardium, for diagnostic, therapeutic, and/or procedural purposes.For example, such system and method may be useful in the placement andmanipulation of a catheter within a patient’s stomach during a procedurefor placement of a gastrostomy tube. Further, such system and method maybe useful in the positioning and manipulation of a suction tube within apatient’s body to remove unwanted fluid, such as by way of an initialsurgical insertion of the suction tube in a region within the patient’sbody that has a low risk of complication or injury, and then finemanipulation of the suction tube in the intended location throughmagnetic guidance from outside of the patient’s body. Similarly, suchsystem and method may be useful for delivering medications through aconduit to targeted regions or organs within the patient’s body, and fordeploying probes, sensors, electrodes, and similarly configured deviceswithin the patient’s body. Still further, such system and method may beuseful in obtaining tissue, fluid, and biopsy samples from within thepatient’s body, such as by magnetically guiding a forcep- or biopsyinstrument-carrier to the intended site within the patient’s body.

As used herein, all of such carriers, catheters, conduits, deliverydevices, internal probes and sensors, electrodes, and the like that areintended for insertion into and movement or manipulation within apatient’s body are referred to generally as “elongate medical members.”

A coaptive ultrasound probe adaptor is provided that is configured tomagnetically attract an elongate medical member, such as a catheter orthe like, positioned within the patient with sufficient force so as toallow the medical operator to manually guide the catheter or otherconduit or elongate medical member to its intended location. The adaptoris also configured to mate with an ultrasound probe, such that as themedical operator is remotely manipulating the catheter or other elongatemedical member, they may likewise receive visual ultrasound feedback ofthe position of the catheter or other elongate medical member within thepatient’s body. By allowing visual confirmation through the use ofreadily-available ultrasound equipment, internal catheter, conduit, orother elongate medical member placement can be achieved without the needfor expensive, specialized equipment, such as endoscopes, fluoroscopes,and CT scanners. Thus, the system and method disclosed herein willenable acute care physicians, such as emergency medicine physicians andcritical care physicians (i.e., intensivists), or other healthcareproviders trained in the art of ultrasound, to place such catheters,conduits, and other elongate medical members safely and reliably.

With regard to certain aspects of an embodiment of the invention, thesystem and method may be used for inserting gastrostomy tubes in asimple bedside procedure without requiring the use of specializedconsultants or specialized equipment including endoscopes, fluoroscopes,and CT scanners. The system and method make use of more widely availablemedical devices that require less specialized training to use, such asultrasounds, feeding tubes, guide wires, and dilators. By allowing awider population of medical operators to perform such procedures, thesystem and method disclosed herein offer safer, more immediate and morecost-effective care. For example, unlike endoscopes, ultrasound ensuresthat an adequate window for percutaneous gastrostomy tube insertion ispresent by providing visual confirmation that no bowel, organs, or bloodvessels obstruct the cannulation track between the skin surface and thestomach wall. Further, with this procedure, emergency medicinephysicians may easily re-insert dislodged gastrostomy tubes andimmediately discharge patients back to their residence instead ofadmitting them for traditional PEG placement to be performed by aspecialist consultant, thus saving time and decreasing consultationcosts, hospital admission costs, patients’ stress, and the risk ofnosocomial infection. Geriatricians and rehabilitation physicians maylikewise use the system and method disclosed herein in nursing home andrehabilitation facilities. This practice could dramatically reduceoverall costs by eliminating transportation costs and thus avoiding allhospital fees.

Still other applications of the disclosed system and method formagnetically attracting an internally positioned elongate medical memberto an externally positioned, ultrasound-enabled adapter for coordinatedmovement and manipulation of the elongate medical member by the adapterwill be apparent to those of ordinary skill in the art without departingfrom the spirit and scope of the invention.

With regard to further aspects of an embodiment of the invention, a kitembodying the system is provided that may also include feeding tubes,guide wires, and dilators.

BRIEF DESCRIPTION OF THE DRAWINGS

The numerous advantages of the present invention may be betterunderstood by those skilled in the art by reference to the accompanyingfigures in which:

FIG. 1 is a schematic view of a gastric tube and ultrasound probeadaptor used for gastrostomy procedures in accordance with certainaspects of an exemplary embodiment of the invention.

FIG. 2 is a side view of the gastric tube of FIG. 1 .

FIG. 3 is a close-up perspective exploded view of the distal end of thegastric tube of FIG. 1 .

FIG. 4 is a close-up side view of the proximal end of the gastric tubeof FIG. 1 .

FIG. 5 a is a schematic, cross-sectional top-down view of the ultrasoundprobe adaptor of FIG. 1 .

FIG. 5 b is a perspective exploded view of an ultrasound probe adaptorin accordance with certain aspects of an embodiment of the invention.

FIG. 6 is a side, cross-sectional view a patient’s abdomen showing thepositioning of an ultrasound probe adaptor in relation to the distal endof a gastric tube of FIG. 1 .

FIG. 7 is a side perspective view of the positioning of an ultrasoundprobe adaptor in relation to the distal end of a gastric tube of FIG. 1in accordance with certain aspects of an exemplary embodiment of theinvention.

FIG. 8 is a flow diagram schematically representing an exemplary methodof performing a gastrostomy in accordance with certain aspects of anembodiment of the invention.

FIG. 9 is a schematic view of the placement of an ultrasound probe on apatient’s body.

FIG. 10 is a schematic view of the insertion of an angiocatheter into apatient’s stomach in accordance with certain aspects of an embodiment ofthe invention.

FIG. 11 is a schematic view of the capture of a guide wire within apatient’s stomach in accordance with certain aspects of an embodiment ofthe invention.

FIG. 12 is a schematic view of a guide wire placed within a patient’sbody in accordance with certain aspects of an embodiment of theinvention.

FIG. 13 shows a kit for placing a conduit within a patient’s body inaccordance with certain aspects of an embodiment of the invention.

BEST MODE(S) FOR CARRYING OUT THE INVENTION

The invention summarized above may be better understood by referring tothe following description, claims, and accompanying drawings. Thisdescription of an embodiment, set out below to enable one to practice animplementation of the invention, is not intended to limit the preferredembodiment, but to serve as a particular example thereof. Those skilledin the art should appreciate that they may readily use the conceptionand specific embodiments disclosed as a basis for modifying or designingother methods and systems for carrying out the same purposes of thepresent invention. Those skilled in the art should also realize thatsuch equivalent assemblies do not depart from the spirit and scope ofthe invention in its broadest form.

FIG. 1 is a schematic view of a system in accordance with certainaspects of an exemplary embodiment of the invention. As shown in FIG. 1, a gastric tube 110 is inserted into a patient’s stomach 185, enteringthe patient through the head 181 (either through the patient’s mouth ornose) and down through the patient’s esophagus 183, with the distal end(shown generally at 120) of gastric tube 110 ultimately being positionedwithin the patient’s stomach. Also as shown in FIG. 1 , an ultrasoundprobe adaptor 200, which is configured to receive an ultrasound probe595, is positionable on the outside of the patient’s abdomen, and may bemanually moved by a medical operator, along with ultrasound probe 595,to provide a visual image of the patient’s abdomen using ultrasoundmethods well known to those of ordinary skill in the art.

Ultrasound probe adaptor 200 and the distal end of gastric tube 110 areconfigured to be magnetically attracted to each other. Moreparticularly, both ultrasound probe adaptor 200 and the distal end ofgastric tube 110 (or other elongate medical member, such as a catheteror conduit member as may be used throughout a patient’s body andparticularly other than in a patient’s stomach) have magnetic members,as will be discussed in further detail below, that provide a sufficientattraction force between them so as to (i) cause the distal end ofgastric tube 110 to come into contact with the internal tissue surfacethat is immediately adjacent the distal end of gastric tube 110 andclosest to probe adaptor 200, and (ii) cause distal end of gastric tube110 to move within the patient’s body in response to movement of probeadaptor 200 and in a motion that corresponds to motion of probe adaptor200 outside of the patient’s body. While the particular magnetic membersnecessary to provide such magnetic attraction may vary, specificconfigurations of such magnetic members will be described by way ofexample in further detail below.

As shown in the detail view of FIG. 2 and in accordance with certainfeatures of an exemplary embodiment, gastric tube 110 comprises a lumen122 extending from proximal end 112 of gastric tube 110 to distal end120 of gastric tube 110. Proximal end 112 of gastric tube 110 may beprovided additional functional elements, including a snare release 114,which provides a mechanism allowing the practitioner to control a snarepositioned at distal end 132. The practitioner may push or pull snarerelease 114 to open or close the snare 132. Further, a syringe port 116may be provided at proximal end 112 of gastric tube 110, providing apassageway to inflate a balloon 124 at the distal end 120 of gastrictube 110. Further, in some embodiments of the invention, one or moreports (not shown) may be provided at proximal end 112 of gastric tube110 to connect external suction or insufflation devices. Such suctionand insufflation ports may connect to one or more lumens that extendalong the length of gastric tube 110.

With continued reference to FIG. 2 , distal end 120 of gastric tube 110includes one or more balloons 124 that may be inflated by thepractitioner, such as by injecting a fluid through syringe port 116 intoballoon 124 via lumen 122. Inflation of the balloon 124 inside of thepatient’s stomach 185 will provide an echogenic space that may beobserved by the practitioner when viewing an ultrasound image of thepatient’s stomach produced by ultrasound probe 595, thus allowing thepractitioner to confirm that the distal end 120 of gastric tube 110 isin its intended location within the patient’s body.

Those skilled in the art will recognize that while a balloon 124 isshown as providing an echogenic space that may be observed viaultrasound, other echogenic configurations that will provide an imagethrough an ultrasound procedure may likewise be provided on an elongatemedical member without departing from the spirit and scope of theinvention.

In order to configure distal end 120 so as to be magnetically attractedto ultrasound probe adaptor 200, distal end 120 is also preferablyconfigured with one or more magnets 126. For example, magnets 126 may bepositioned within and fixedly attached to the interior walls of balloon124. Alternatively or additionally, magnets 126 may be located along theshaft of distal end 120 of gastric tube 110, and may be positionedinternally along the distal end 120 of gastric tube 110, or externally(such as by clipping, by adhesive attachment, or otherwise) along thedistal end 120 of gastric tube 110 or on the outside of balloon 124,without departing from the spirit and scope of the invention. Manydifferent configurations of magnets 126 may be used in order to ensureproper alignment with and attraction to ultrasound adaptor 200.

Still further, distal end 120 of gastric tube 110 may be provided one ormore tube fenestrations 140 that communicate with suction and/orinsufflation ports at proximal end 112 of gastric tube 110, if suchports are provided. Likewise, snare 132 is located at distal end 120 ofgastric tube 110, which snare 132 communicates with a snare operator,such as snare release 114, via snare line 130.

FIG. 3 shows a close-up exploded view of distal end 120 of gastric tube110 according to certain aspects of an exemplary embodiment of theinvention. As shown in FIG. 3 , gastric tube 110 may be a generallycylindrical tube, and fenestrations 140 may be provided at the end ofgastric tube 110 and aligned in axially-extending rows around thecircumference of the end of gastric tube 110. Lumen 122 extends throughgastric tube 110. Likewise, a flexible, inflatable balloon, which may beformed in varying shapes and sizes, is affixed to the end of gastrictube 110 and is in fluid communication with lumen 122 so that it may beinflated from the proximal end of gastric tube 110 with an echogenicmedium, contrast agent or therapeutic agent. One or more magnets 126,such as by way of non-limiting example a neodymium block magnet havingan approximate thickness of ¼”and an approximate length of 11/2”, isalso situated in the distal end 120 of gastric tube 110, and may bepositioned within balloon 124, within lumen 122, or bridging a portionof both balloon 124 and lumen 122. Further, magnet 126 may be rigidlyaffixed to balloon 124 and/or lumen 122, or may alternatively bepositioned therein without fixation, so long as magnet 126′s positionwill cause balloon 124 to be magnetically drawn toward ultrasound probeadaptor 200 when the probe adaptor is placed against the patient’sabdomen. In a most preferred configuration, magnets 126 are situatedalong opposite side edges of balloon 124 so as to allow them to alignwith magnets positioned on ultrasound adaptor 200, as further detailedbelow. Snare 132 and snare line 130 are not shown in FIG. 3 for clarity,but those skilled in the art will recognize that such elements would bepresent and in a configuration as is well known in the art.

FIG. 4 provides a close-up view of syringe port 116 located at theproximal end of gastric tube 110. In the illustrated embodiment, syringeport 116 is attached to a syringe 118. Syringe 118 may be filled withany type of fluid that is capable of expanding balloon 124 with anechogenic medium, contrast agent or therapeutic agent. In preferredembodiments, syringe 118 is filled with a non-toxic fluid that willenhance ultrasound imaging, such as by way of non-limiting example,water or saline. Gases may also be used to inflate balloon 124. Whilethe illustrated embodiment shows syringe 118 being a removable element,in certain embodiments syringe 118 may be a permanent element, makingthe fluid transfer system between syringe 118 and balloon 124 a closedsystem.

Next, FIG. 5 a shows a schematic, cross-sectional top-down view of acoaptive ultrasound probe adaptor 200 in accordance with certain aspectsof an embodiment of the invention. Adaptor 200 may be formed in avariety of different shapes to receive existing or yet-to-be-developedultrasound probes. As used herein, “ultrasound probe” is intended torefer to any hand-held device configured to provide ultrasound imaging.Ultrasound probe adaptor 200 includes a magnetic source, and isphysically configured so as to attach to an ultrasound probe 595. In theembodiment shown in FIG. 5 a , the magnetic source comprises anelectromagnet having a power source 220, a variable resistor dial 240,and a coil 230, all contained within an external housing 210. Likewise,in order to attach to an ultrasound probe in the illustrated embodimentof FIG. 5 a , housing 210 is provided an ultrasound probe receiver, suchas a central cavity 215, into which the scanning head of an ultrasoundprobe may be inserted. Alternatively, adaptor 200 may attach to anultrasound probe 595 by clipping on to one or more edges of the probe,or in other ways as may be apparent to those of ordinary skill in theart. Likewise, while the illustrated embodiment of FIG. 5 a depicts asingle electromagnetic configuration, other magnetic configurations andtypes may be used, such as ferromagnets positioned within housing 210,without departing from the spirit and scope of the invention. Likewise,variable resistor dial 240 or other adjustment devices may be used toincrease or decrease the magnetic force of coil 230, in static oralternating frequency patterns, or alternatively no adjustment devicemay be provided, again without departing from the spirit and scope ofthe invention.

FIG. 5 b shows a close-up exploded view of a coaptive ultrasound probeadaptor 200, along with an ultrasound probe 595, according to certainaspects of a particularly preferred embodiment of the invention. Asshown in FIG. 5 b , ultrasound probe adaptor 200 includes base 210having central cavity or opening 215 centrally located in the base 210and extending through the entire thickness of base 210, such thatultrasound probe 595 may be placed in opening 215 and in contact with apatient’s skin on which ultrasound probe adaptor 200 is positioned. Withregard to an aspect of a particularly preferred embodiment of theinvention, opening 215 is sized having a width dimension that is lessthat the width of balloon 124 on gastric tube 110, such that the sidesof the balloon 124 extend past the long side edges of opening 215 whenballoon 124 is magnetically attracted to ultrasound probe adaptor 200.Further, magnet receiving slots 217 are positioned at opposing sides ofopening 215, and are each configured to removably receive a magnet 245 aand 245 b therein. Preferably, the magnets 245 a and 245 b are situatedin opposite orientations from one another within their respective slotsin ultrasound probe adaptor 200. As a result, the practitioner isassured that ultrasound probe adaptor 200 will magnetically attract aballoon 124, regardless of the orientation of the balloon 124 within thepatient’s body (i.e., regardless of which magnet pole is facing towardsultrasound probe adaptor 200). In one embodiment, ultrasound probeadaptor 200 is configured to position magnets 245 a and 245 b a distanceaway from one another that approximately matches the distance betweenmagnets 126 positioned in balloon 124 so as to provide for alignment ofthe long axes of balloon 124 and ultrasound probe adaptor 200 when thetwo are magnetically attracted to one another. A first cover plate 247 amay cover the magnet receiving slot 217 that receives magnet 245 a, anda second cover plate 247 b may cover the magnet receiving slot 217 thatreceives magnet 245 b. Each such cover plate 247 a and 247 b ispreferably removably held over its designated receiving slot 217 withremovable connectors, such as threaded bolts 248 that extend into nuts249 that in turn are held within base 110. As cover plates 247 a and 247b are removable, and as magnets 245 a and 245 b are removable from slots217, magnets of varying strength may be positioned within slots 217 soas to vary the amount of magnetic attraction that will be realizedbetween ultrasound probe adaptor 200 and balloon 124, which may benecessary for varying medical procedures and varying patient physiology(i.e., with larger tissue planes between the ultrasound probe adaptor200 and balloon 124 requiring larger magnetic attraction and in somecases repulsion).

Next, FIG. 6 shows a cross-sectional view and FIG. 7 a perspective viewof the coaptive ultrasound probe adaptor 200 interacting with balloon124 through a tissue plane. More particularly, the distal end 120 ofgastric tube 110 having balloon 124 is shown in FIG. 6 positioned insideof a patient’s stomach, with ultrasound probe adaptor 200 positionedoutside of the patient’s body and in contact with the skin of thepatient’s abdomen. In the illustrated embodiment, ultrasound probeadaptor 200 is positioned directly against the patient’s skin 393, andthe magnetic forces that attract balloon 124 to ultrasound probe adaptor200 extend through the patient’s skin 393, through the subcutaneoustissue 391, and through the stomach wall 395 (such tissue planes beinghidden in FIG. 7 for clarity). Magnetic members in each of ultrasoundprobe adaptor 200 and balloon 124, such as magnets 126, cause balloon124 to come into contact with stomach wall 395 and to push stomach wall395 against the subcutaneous tissue 391 of the patient’s abdomen(defined as coaptation), thus easing access to balloon 124 with aneedle, cannula, or other device as described in greater detail below.Moreover, as best seen in FIG. 7 , the position of magnets 126 inballoon 124 and of magnets 245 a and 245 b in ultrasound probe adaptor200 may cause the balloon 124 and adaptor 200 to align their long axeswith one another, and allow coordinated movement between the two.

FIG. 8 is a flow diagram that depicts one method of performing agastrostomy using the system of the present invention. Although stepsare depicted in FIG. 8 as integral steps in a particular order forpurposes of illustration, in other embodiments, one or more steps, orportions thereof, are performed in a different order, or overlapping intime, in series or in parallel, or are omitted, or one or moreadditional steps are added, or the method is changed in some combinationof ways. Some of the steps are illustrated in FIGS. 9 through 12 .Moreover, while such method steps are specifically recited ascorresponding to the performance of a gastrostomy, such gastrostomyprocess is referenced as exemplary only, and those of ordinary skill inthe art will recognize that such method may be readily modified for manyother procedures benefitting from remote, magnetic manipulation of anelongate medical member under ultrasound guidance using the generalcoaptive ultrasound methods shown in FIG. 8 without departing from thespirit and scope of the invention.

First, in step 802, a gastric tube 110 configured as above is insertedthrough a patient’s nose or mouth until the distal end 120 of thegastric tube 110 is positioned inside of the patient’s stomach. Existingstomach contents are extracted, for example by applying suction throughfenestrations 140 in the gastric tube 110. Next, the stomach isinsufflated, for example by using both the same or different channelsand fenestrations in the gastric tube 110. Syringe 118 is filled withnon-toxic fluid. In steps 803 and 804, ultrasound probe 595 and adaptor200 are placed on the patient’s abdomen 590 (as shown in FIG. 9 ). Ifthe ultrasound probe adaptor is provided an electromagnet, it isactivated at this time. As a result of the magnetic attraction betweenthe ultrasound probe adaptor 200 and the distal end of gastric tube 120,the two components will align with one another along their long axes.Next, a suitable entry point is identified in step 805. Ultrasound probe595 is used to ultrasonically image the patient’s internal abdomen todetect any interposed organs or large vessels positioned between theultrasound probe adaptor 200 and the balloon 124.

In the event that ultrasound probe adaptor 200 is provided anelectromagnet assembly, the strength of the magnet may be adjusted usingthe variable resistor dial 240. Likewise, if ferromagnets are positionedin ultrasound probe adaptor 200, the strength of the magnetic forcegenerated by ultrasound probe adaptor 200 may be modified by simplychanging the magnets 245 a and 245 b in adaptor 200. In some cases, itmay be necessary to reduce the magnetic attraction to allow forcoordinated movement of the devices until a suitable entry point isidentified. In other instances, it may be necessary to increase themagnetic attraction to account for excessive subcutaneous tissue. In anycase, once a proper entry point is identified, the depth of thesubcutaneous tissue may be measured to give the practitioner a referencepoint before making an incision.

Next, in step 806, and as shown in FIG. 10 , an inner needle 583 andangiocatheter 580 are inserted into the patient’s stomach through theabdomen, preferably through opening 215 in adaptor 200 Inner needle 583is then removed in step 807, and in step 808 (and as shown in FIG. 11 ),guide wire 582 is introduced through angiocatheter 580. Once the distalend 587 of guide wire 582 is fed through snare 132, snare 132 is closedand the balloon 124 is deflated in step 809. Next, gastric tube 110 isremoved from the patient in step 810, and snare 132 is released in step811 when the gastric tube is completely removed. FIG. 12 shows the finalresult of the method, in which guide wire 582 extends from the patient’sstomach 185, through the esophagus 183, and out through the patient’shead 181. The proximal end 589 terminates outside of the patient’sstomach. The distal end 587 terminates outside of the patient’s nose ormouth. Once guide wire 582 is in place, the feeding tube may be insertedat step 812 using either the Ponsky-Gauderer method or the Sacks-Vinemethod, as described above.

In another embodiment, the devices of the present invention are used tointroduce a percutaneous gastrostomy tube into a patient usinggastropexy methods. In this method, steps 802 through 807 remain thesame. However, after the inner needle is removed, one or more gastropexyanchors are inserted into the patient’s stomach. Once the one or moreanchors are fixated, standard gastrostomy methods follow using a guidewire placed only within the stomach.

FIG. 13 shows a kit for placing an elongate medical member, such as aconduit, within a patient’s body in accordance with certain aspects ofan embodiment of the invention. As shown in FIG. 13 , a kit preferablyincludes at least an ultrasound probe adaptor 200 configured asdescribed above, a conduit 110, a syringe 118 for connection to aproximal end of conduit 110, a plurality of inflatable balloons 124 forconnection to the distal end of conduit 110, and at least one magnet 126sized for insertion into each of balloons 124. Preferably, more than onemagnet 126 is provided, with the magnets preferably having differingmagnetic strengths that a practitioner may select for a particularcircumstance (e.g., for tissue planes of varying thickness). Also, whilenot shown in FIG. 13 , additional elements could be provided with such akit, including items such as feeding tubes or other supply or fluiddrainage conduits, guide wires, dilators, and the like, all withoutdeparting from the spirit and scope of the instant invention.

In the foregoing specification, the invention has been described withreference to specific embodiments thereof. It will, however, be evidentthat various modifications and changes may be made thereto withoutdeparting from the broader spirit and scope of the invention. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than a restrictive sense. Throughout thisspecification and the claims, unless the context requires otherwise, theword “comprise” and its variations, such as “comprises” and“comprising,” will be understood to imply the inclusion of a stateditem, element or step or group of items, elements or steps but not theexclusion of any other item, element or step or group of items, elementsor steps. Furthermore, the indefinite article “a” or “an” is meant toindicate one or more of the item, element or step modified by thearticle.

Having now fully set forth the preferred embodiments and certainmodifications of the concepts underlying the present invention, variousother embodiments as well as certain variations and modifications of theembodiments herein shown and described will obviously occur to thoseskilled in the art upon becoming familiar with said underlying concepts.It should be understood, therefore, that the invention may be practicedotherwise than as specifically set forth herein.

INDUSTRIAL APPLICABILITY

The present invention is applicable to devices and methods for placingmedical devices into and manipulating such medical devices withinpatients, particularly through ultrasound-guided placement andmanipulation. The devices can be made in industry and practiced in themedical device field.

1-29. (canceled)
 30. A system for coaptive ultrasound visualization,comprising: a first component configured to be placed on a first side ofa tissue layer, the first component including a magnetic field source;and a second component, having one or more echogenic properties,configured to be placed on a second side of the tissue layer and withinan organ, the second component having a proximal end and a distal end,the distal end including a magnetic force receiver configured tointeract with a magnetic field generated by the magnetic field sourceand to generate a force between said first component and said distal endof said second component, wherein said force causes (i) the distal endof the second component to move in a direction within the organ towardthe first component, thereby pushing against the organ and causing apersistent area of coaptation between at least part of said organ andthe second side of the tissue layer while the first component isgenerating the magnetic field and the distal end of the second componentis within the organ; and (ii) coordinated movement between said firstcomponent and said second component; an ultrasound visualizationcomponent including an ultrasound probe and a display, the ultrasoundprobe configured to be placed on the first side of the tissue layer andadjacent the first component, the ultrasound probe configured togenerate one or more ultrasonic images of the persistent area ofcoaptation for delivery to the display, and the display configured tooutput the one or more ultrasonic images of at least the persistent areaof coaptation.
 31. The system of claim 30, wherein the magnetic forcereceiver includes an electromagnet.
 32. The system of claim 30, whereinthe magnetic force receiver includes a permanent magnet.
 33. The systemof claim 30, wherein the magnetic force receiver includes a paramagneticmaterial.
 34. The system of claim 30, wherein the one or more echogenicproperties include at least one of an acoustic property, a metallicproperty and a property that resonates with ultrasound waves.
 35. Thesystem of claim 30 wherein the distal end of the second componentincludes an expandable balloon defining an echogenic interior volume.36. The system of claim 35, wherein the expandable balloon is configuredto receive a needle through the balloon while the balloon is in anexpanded state.
 37. The system of claim 36, wherein the expandableballoon includes a material that can retain an echogenic fluid.
 38. Thesystem of claim 37, wherein the expandable balloon can retain theechogenic fluid after receipt of the needle through the balloon in anexpanded state.
 39. The system of claim 35 further comprising aguidewire.
 40. The system of claim 39, wherein the expandable ballooncan receive the guidewire into the interior volume of the balloon.
 41. Amethod for coaptive ultrasound visualization, comprising: positioning afirst component on a first side of a tissue layer, the first componentincluding a magnetic field source generating a magnetic field; andpositioning a second component, having one or more echogenic properties,on a second side of the tissue layer and within an organ, the secondcomponent having a proximal end and a distal end, the distal endincluding a magnetic force receiver interacting with the magnetic fieldand generating a force between said first and said distal end of saidsecond component, wherein said force causes (i) the distal end of thesecond component to move in a direction within the organ toward thefirst component, thereby pushing against the organ and causing apersistent area of coaptation between at least part of said organ andthe second side of the tissue layer while the first component isgenerating the magnetic field and the distal end of the second componentis within the organ; and (ii) coordinated movement between said firstcomponent and said second component; and placing an ultrasound probe onthe first side of the issue layer and adjacent the first component,wherein the ultrasound probe generates one or more ultrasonic images ofthe persistent area of coaptation; transmitting the one or moreultrasonic images of the persistent area of coaptation to a display;displaying, on the display, the one or more ultrasonic images of thepersistent area of coaptation.
 42. The method of claim 41 furthercomprising moving the first component on the first side of the tissuelayer in a first direction and thereby causing the second component onthe second side of the tissue layer to move in said first direction. 43.The method of claim 41 further comprising moving the first component onthe first side of the tissue layer in a first direction and therebycausing the second component on the second side of the tissue layer tomove in a second direction different from said first direction.
 44. Themethod of claim 41 further comprising inflating a balloon surroundingthe second component into an inflated state defining an echogenicinterior volume.
 45. The method of claim 44 further comprisinggenerating one or more ultrasonic images of the echogenic interiorvolume of the inflated balloon.
 46. The method of claim 45 furthercomprising inserting a needle into the inflated balloon surrounding thesecond component.
 47. The method of claim 45 further comprisinginjecting a therapeutic in an area adjacent the second component. 48.The method of claim 45 further comprising infusing a therapeutic into anarea adjacent the inflated balloon.
 49. The method of claim 44 furthercomprising inserting a guidewire into the inflated balloon surroundingthe second component.
 50. The method of claim 44 wherein inflating aballoon surrounding the second component into an inflated statecomprises inflating the balloon with one or more therapeutics.
 51. Themethod of claim 41 further comprising: guiding a biopsy instrument to anarea adjacent the second component; and retrieving a biopsy sample viathe biopsy instrument.
 52. The method of claim 41 further comprisingdeploying at least one of a sensor, probe, electrode and therapeutic toan area adjacent the second component.
 53. The method of claim 41further comprising placing an active medical device adjacent an areaadjacent the second component, the active medical device including atleast one of a radioactive seed, temperature probe and temperatureelement.
 54. The method of claim 41 further comprising suctioning anarea adjacent the second component.
 55. The method of claim 41 furthercomprising insufflating an area adjacent the second component with atleast one of air or fluid.
 56. The method of claim 41 further comprisingdraining fluid from an area adjacent the second component by at leastone of suctioning and lavaging.